# K214009: D·Kaptain PTA High Pressure Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medical Technology Co., Ltd.
- Decided: Apr 5, 2023 after 516 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103751: Mustang Balloon Dilatation Catheters, Boston Scientific (2011) Summary page 4.

## Indications for use
The D∙Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

Source page: https://510kreport.com/device/K214009
Methodology: https://510kreport.com/methodology